Trial reportArchives of disease in childhood. Fetal and neonatal edition2023
Caffeine to prevent intermittent hypoxaemia in late preterm infants: randomised controlled dosage trial.
Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Methylxanthines for the prevention or treatment of intermittent hypoxemia or respiratory insufficiency in late preterm infants.The Cochrane database of systematic reviews · 2026Pooled it
- Apnoea duration and changes in cardiorespiratory and cerebrovascular responses in preterm neonates: a systematic review and meta-analysis.Pediatric research · 2026Pooled it
- Caffeine for apnea and prevention of neurodevelopmental impairment in preterm infants: systematic review and meta-analysis.Journal of perinatology : official journal of the California Perinatal Association · 2024Pooled it
- Methylxanthine for the prevention and treatment of apnea in preterm infants.The Cochrane database of systematic reviews · 2023Pooled it
- Oral doxapram for apnea of prematurity: A randomized dosage trial.Journal of perinatology : official journal of the California Perinatal Association · 2026Trial
- Cumulative caffeine exposure predicts neurodevelopmental outcomes in premature infants.Pediatric research · 2026Article
- Editorial: Evaluating efficacy and outcomes in neonatal HIE treatment: A global perspective.Frontiers in pediatrics · 2026Article
- Methylxanthines: The Major Impact of Caffeine in Clinical Practice in Patients Diagnosed with Apnea of Prematurity.Journal of clinical medicine · 2025Review
- Reducing the risk of sudden unexpected infant death: the caffeine hypothesis.Journal of perinatology : official journal of the California Perinatal Association · 2025Review
- The Clinical Relevance of Overnight Oximetry in the Diagnosis of Intermittent Desaturations and the Need for Home Oxygen in the Near-Term and Term Infant.Children (Basel, Switzerland) · 2025Review
- Article
- Caffeine for Persistent Intermittent Hypoxia in Newborns With and Without Chronic Lung Disease.Pediatric pulmonology · 2025Article
- Pharmacological treatment for apnoea of prematurity-the need for an individualised approach.Frontiers in pediatrics · 2025Review
- Caffeine use in preterm neonates: national insights into Turkish NICU practices.Frontiers in pediatrics · 2025Article
- Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo establish the most effective and best tolerated dose of caffeine citrate for the prevention of intermittent hypoxaemia (IH) in late preterm infants.
designPhase IIB, double-blind, five-arm, parallel, randomised controlled trial.
settingNeonatal units and postnatal wards of two tertiary maternity hospitals in New Zealand.
participantsLate preterm infants born at 34
interventionInfants were randomly assigned to receive a loading dose (10, 20, 30 or 40 mg/kg) followed by 5, 10, 15 or 20 mg/kg/day equivolume enteral caffeine citrate or placebo daily until term corrected age. PRIMARY OUTCOME: IH (events/hour with oxygen saturation concentration ≥10% below baseline for ≤2 min), 2 weeks postrandomisation.
results132 infants with mean (SD) birth weight 2561 (481) g and gestational age 35.7 (0.8) weeks were randomised (24-28 per group). Caffeine reduced the rate of IH at 2 weeks postrandomisation (geometric mean (GM): 4.6, 4.6, 2.0, 3.8 and 1.7 events/hour for placebo, 5, 10, 15 and 20 mg/kg/day, respectively), with differences statistically significant for 10 mg/kg/day (GM ratio (95% CI] 0.39 (0.20 to 0.76]; p=0.006) and 20 mg/kg/day (GM ratio (95% CI] 0.33 (0.17 to 0.68]; p=0.003) compared with placebo. The 20 mg/kg/day dose increased mean (SD) pulse oximetry oxygen saturation (SpO
conclusionCaffeine reduces IH in late preterm infants at 2 weeks of age, with 20 mg/kg/day being the most effective dose. TRIAL REGISTRATION NUMBER: ACTRN12618001745235.
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